Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202302664171196 Date of Approval: 24/02/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Clinical management of loiasis in high transmission regions of Gabon
Official scientific title Clinical management of loiasis in high transmission regions of Gabon
Brief summary describing the background and objectives of the trial Background: - Treatment options for loiasis, a filarial disease caused by infection with Loa loa, are currently limited by the very few drugs of any known efficacy and the risk of severe adverse reactions in patients with high microfilarial loads. Moreover, current treatment regimens are usually recommended for microfilaremic loiasis and usually do not differentiate between occult loiasis (symptomatic loiasis without microfilariae in the blood) and microfilaremic loiasis (microfilariae in the blood). Optimisation of regimens for the safe reduction of Loa loa microfilariae could contribute to curing the disease and may reduce onwards transmission. This randomised controlled open-label clinical phase 3 trial will evaluate the efficacy, safety, and tolerability of different treatment regimens in a sub-sample of individuals with microfilariemic loiasis and a sub-sample of occult loiasis for reducing Loa loa microfilaremia and/or the reduction of Loa loa associated symptoms and signs in endemic regions of Gabon. Primary Objective: - To evaluate the patient centred outcomes among individuals with occult loiasis of each treatment arm at baseline, at DT+ 7, 28,months 3 and 6 after treatment initiation
Type of trial RCT
Acronym (If the trial has an acronym then please provide) LoaCare
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Loiasis
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2023
Actual trial start date 01/05/2023
Anticipated date of last follow up 31/12/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group P tablets The recommended dosage for the purpose of this study is one P-tablet (210mg/day) preferably in the evening. 10 days P-tablets (210 mg/day), an inactive tablet containing lactose-monohydrat, potato starch and corn starch will be used as placebo. Participants will be seen at screening immediately prior to initiation of the study arm, and at DT+1, 3, 7, 14, 21, 28, month 2, 3 and 6. The treatment will be defined as successful on a patient-centred perspective when composites of PROMs have been relatively reduced. At the end of the study, the patients will be offered the standard of care therapy of loiasis which is constituted by 21 days of albendazole (400 mg/day) therapy. 30 Placebo
Experimental Group Ivermectin a single oral dose designed to provide approximately 200 µg/kg of ivermectin per kg of body weight. one single dose IVM - semisynthetic macrolide - only targets the microfilariae and is thought to not have an effect on adult worms in individuals suffering from loiasis. IVM should not be given to individuals with a high microfilarial density, as it leads to severe adverse events (5). Participants with occult loiasis will receive a 200 µg/kg single dose of IVM. 30
Experimental Group Albendazole 400 mg/day 400mg/day for 28 days Albendazole (ALB) can potentially slowly lower microfilaremia (5). Furthermore, ALB has a primary effect on the adult parasites. Participants with occult loiasis will receive ALB 400 mg once a day for 28 days. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Participants of either sex (≥18 years) - Intention to remain residing in study area and comply with study procedures throughout the follow-up period - Positive RAPLOA assessment within the last years - Signed written informed consent - mf - Known intolerance or allergy to any study drug - Known acute viral hepatitis (HBV, HCV) or other known acute active liver disease - Known acute HIV infection or other known immunosuppressive condition - History of epilepsy, encephalitis, meningitis or encephalopathy, severe alcohol abuse - Any other acute or chronic medical condition, medication or psychosocial factor(s) deemed by the Investigator to put the potential participant at greater than acceptable risk or to significantly affect study outcomes - Pregnancy, breastfeeding, and unwillingness to use any type of contraceptive method for women with childbearing potential - Any anti-filarial treatment in the past 4 weeks (ivermectin, >5 days of albendazole or mebendazole, DEC, >3 weeks of doxycycline or tetracycline) - Uncomplicated loiasis (as evidence by absence of end organ complications: signs or symptoms of end organ complication including heart failure, respiratory distress, or renal insufficiency) - Abusive alcohol consumption 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 200 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/12/2022 Institutional Ethics Committee
Ethics Committee Address
Street address City Postal code Country
BP 242 Lambaréné 0 Gabon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Superiority trial of treatment regimens compared to placebo for PROMs (relative reduction of composite PROMs) at DT+ 7, 28,month 3 and 6 after treatment initiation Day 7, 28, and 3, 6 months
Secondary Outcome - Safety and tolerability assessed by the occurrence of all adverse events (AE) at least possibly related to study drug up to day 28 - Patient-centred efficacy assessed by a- The proportion of participants with symptoms possibly related to loiasis during the study period at baseline, at DT+ 7, 28, month 3 and 6 after treatment initiation b- The median reduction (IQR) of eosinophile count at DT+1, 3, 7, 14, 21, 28, 2, 3, and 6 months after treatment initiation and at nadir DT, 1, 3, 7, 14, 21, 28, and 2, 3, and 6 months after treatment initiation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre de Recherches Medicales de Lambarene 242 Lambarene Gabon
FUNDING SOURCES
Name of source Street address City Postal code Country
Deutsche Gesellschaft fuer Internationale Zusammenarbeit Friedrich-Ebert-Allee 32-36 Bonn 53113 Germany
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Bernhard Nocht Institute for Tropical Medicine Bernhard-Nocht-Strasse 74 Hamburg 20359 Germany Individual
COLLABORATORS
Name Street address City Postal code Country
Centre de Recherches Medicales de Lambarene 242 Lambarene Gabon
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Saskia Davi saskia.davi@bnitm.de +4940285380519 Bernhard-Nocht-Strasse 74
City Postal code Country Position/Affiliation
Hamburg 20359 Germany Scientific Research Staff in Clinical Research Departement at the Bernhard Nocht Institute for Tropical Medicine
Role Name Email Phone Street address
Scientific Enquiries Michael Ramharter ramharter@bnitm.de +4940285380511 Bernhard-Nocht-Strasse 74
City Postal code Country Position/Affiliation
Hamburg 20359 Germany Head of the Clinical Research Department at the Bernhard Nocht Institute for Tropical Medicine
Role Name Email Phone Street address
Public Enquiries Cedric Mbavu cedric.mbavu@bnitm.de +4940285380519 Bernhard-Nocht-Strasse 74
City Postal code Country Position/Affiliation
Hamburg 20359 Germany Project Manager in Clinical Research Department at the Bernhard Nocht Institute for Tropical Medicine
Role Name Email Phone Street address
Principal Investigator Rella Zoleko Manego manegorella@yahoo.fr +24177155748 242
City Postal code Country Position/Affiliation
Lambarene Gabon Research Physician at the Centre de Recherches Medicales de Lambarene
Role Name Email Phone Street address
Scientific Enquiries Ghyslain Mombo Ngoma mombo.ngoma@cermel.org +24166072578 242
City Postal code Country Position/Affiliation
Lambarene Gabon Head of the Clinical Operations Department at the Centre de Recherches Medicales de Lambarene
Role Name Email Phone Street address
Public Enquiries Marisca Tsoni Malekou mariscatsoni07@gmail.com +24177720053 242
City Postal code Country Position/Affiliation
Lambarene Gabon Project Manager at the Centre de Recherches Medicales de Lambarene
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will only be available after it has been deidentified. After deidentification, the individual participant data that underlie the results will only be reported in a publication in the form of text, tables, figures and appendices. The study protocol will not be available. The time-frame remains unknown and access criteria will be assessed at a later time. Informed Consent Form,Statistical Analysis Plan,Study Protocol Undecided: It is not yet known if there will be a plan to make IPD available and if so in which time frame Upon reasonable request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information